Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cure Medical, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132500 | CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUD | Cure Medical, LLC | 2013-12-23 | 136 | 0 |
| K110653 | CURE CATHETER | Cure Medical, LLC | 2011-08-01 | 147 | 1 |
| K080881 | CURE CATHETER CLOSED SYSTEM | Cure Medical, LLC | 2008-06-11 | 72 | 0 |
| K072539 | CURE CATHETER | Cure Medical, LLC | 2007-09-13 | 3 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda